MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES ADULT; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60A180
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the speaking valve detaches from the connector.It was stated that it had happened with two different speaking valves.The homecare provider unfortunately already disposed.She therefore assumes that it's due to the cannula.The exact event date is unknown since the homecare provider spontaneously mentioned this issue to our sales rep.When she was at the patients home.However, it must have happened before (b)(6) 2022, because on this day we received the information that the cannula would be returned.Event occurred after trach change.
Additional Manufacturer Narrative
H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection did not identify any anomalies.Functional testing with three different types of accessories were seated on the connector (i.E., dual axis swivel adapter, sideport, and a red cap).There were no difficulties seating the accessories; they remained seated even with the device was rotated upside down.The investigation did not identify a defect with the iso taper of the connector on the returned sample.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: BIVONA TUBES ADULT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15755233
• Report Number: 3012307300-2022-26909
• Device Sequence Number: 6321933
• Product Code: JOH
• UDI-Device Identifier: 15021312005578
• UDI-Public: 15021312005578
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K913859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60A180
• Device Catalogue Number: 60A180
• Device Lot Number: 4209605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown